Data / Medical devices / United States / PULMONX, Corp.

PULMONX, Corp.: FDA-registered device maker in Redwood City, CA, United States, 6 510(k) clearances and 1 PMA approval

Name: PULMONX, Corp. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

PULMONX, Corp. is registered with the FDA (registration 3007797756) in Redwood City, CA, United States. It lists 5 device types. The FDA files 6 510(k) clearances and 1 PMA approval under its listings, the newest dated February 13, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch PULMONX, Corp.

FDA registration number: 3007797756
Address: 700 Chesapeake Drive, Redwood City, CA, United States, 94063
Owner or operator: Pulmonx, Corp. (10029906)
Roles: Complaint file establishment, Manufacturer, Manufacturer for export
First device listed: January 2, 2013
Registered through: 2026
Brand names listed: AeriSeal System, Chartis Catheter, Chartis Console, Chartis Tablet Console, Lung Image Analysis, Zephyr 4 Endobronchial Delivery Catheter, Zephyr 4 Endobronchial Valve, Zephyr 4-J Endobronchial Delivery Catheter and more

Devices it lists

Device	Product code	Class	Role	Source
Lung Tissue Sealant For Lung Volume Reduction	POI	N	Manufacturer for export	accessdata.fda.gov
Spirometer, Diagnostic	BZG	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	CBI	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Valve, Pulmonary	NJK	3	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 13, 2026	K253096	Chartis Precision Catheter	CBI	Substantially Equivalent	Pulmonx Corporation	accessdata.fda.gov
December 1, 2022	K222340	Chartis Precision Catheter	CBI	Substantially Equivalent	Pulmonx Corporation	accessdata.fda.gov
September 2, 2021	K212494	Lung Image Analysis	JAK	Substantially Equivalent	Pulmonx Corporation	accessdata.fda.gov
July 13, 2018	K180011	Pulmonx Chartis Tablet Console	BZG	Substantially Equivalent	Pulmonx Corporation	accessdata.fda.gov
November 10, 2011	K111764	CHARTIS CONSOLE	BZG	Substantially Equivalent	Pulmonx, Inc.	accessdata.fda.gov
September 29, 2011	K111522	CHARTIS CATHETER MODEL CHR-CA-12.0	CBI	Substantially Equivalent	Pulmonx, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
June 29, 2018	P180002	Zephyr Endobronchial Valve System	NJK	29	September 11, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 31, 2023	93179	Class II	Ongoing	Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP	Endobronchial implant devices may have been labeled with a shortened expiration date but they can be used until the correct expiration date: 08 December 2024.	accessdata.fda.gov

Compare with other makers

Updated September 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.